SERIES III RUN-IN Clinical Trial: A Comparison of the Supralimus® Stent With the Xience V™ Stent

Coronary Artery Disease Clinical Trial

Official title:

A Randomized Comparison of the Supralimus® Stent With the Xience V™ Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00917163
• Other study ID #: SES/RCT/01
• Status: Terminated
• Phase: Phase 4
• First received: June 8, 2009
• Last updated: August 22, 2012
• Start date: July 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2012
• Source: Sahajanand Medical Technologies Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyIndia: Drugs Controller General of IndiaSaudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The objective of Series III Run-In Trial is to compare the performance and efficacy of the Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect to in-stent luminal late loss at 9 months as assessed by off-line QCA. Ninety percent power to reject the null hypothesis that the Supralimus® stent is inferior to Xience V™ in favor of the alternative hypothesis that the Supralimus® stent is not inferior to Xience V™.

Description:

Series III Run-In is a prospective, multi-center, randomized, single-blind (patient-blind), non-inferiority trial to be conducted at approx. 35 interventional cardiology centers in India, Brazil, Argentina, Thailand and Saudi Aurabia. A total of 360 will be randomized on a 2:1 basis to either the Supralimus® (sirolimus-eluting) stent or the Xience V™ (everolimus-eluting) stent.

In selected sites, IVUS will also be recorded in these patients (maximum of 60 IVUS patients in total), at baseline (post-procedure) and at 9-month follow-up.

All patients will be followed clinically for up to 5 years after stent implantation. Repeat angiography will be performed in all patients at 9 months after the index procedure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Age =18 years.

2. Eligible for percutaneous coronary intervention (PCI)

3. Acceptable candidate for CABG

4. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia.

5. The target lesion is a single de novo coronary artery lesion with = 50% and < 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent.

6. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.

7. The target lesion must be = 22 mm in length by visual estimate.

8. The target reference vessel diameter must be = 2.5 mm and = 3.5 mm.

9. Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the clinical site.

Exclusion Criteria:

1. Female of childbearing potential

2. Documented left ventricular ejection fraction (LVEF) = 30%

3. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure

4. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, sirolimus, everolimus, stainless steel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated)

5. A platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3

6. Acute or chronic renal dysfunction (creatinine >2.0mg/dl or >150µmol/L)

7. Total occlusion (TIMI 0) or TIMI 1

8. Target vessel has evidence of thrombus

9. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment

10. Previous bare metal stenting (less than 1 year) anywhere within the target vessel

11. Previous drug-eluting stenting anywhere within any epicardial vessel

12. The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)

13. Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off

14. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated

15. Target lesion is located in or supplied by an arterial or venous bypass graft

16. Ostial target lesion

17. Target lesion involves a side branch >2.0mm in diameter with an ostial disease

18. Patient is currently participating in an investigational drug or device study, including its follow-up period

19. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind

20. Within 60 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.

21. Stroke or transient ischemic attack within the prior 6 months

22. Unprotected Left Main (LM) coronary artery disease (stenosis >50%)

23. In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study

24. Planned surgery within 6 months after the index procedure

25. Life expectancy less than 1 year

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Supralimus(R) Sirolimus-Eluting Coronary Stent System
Drug eluting stent implantation in the treatment of coronary artery disease.
• Xience V™ Everolimus Eluting Coronary Stent
Drug eluting stent implantation in the treatment of coronary artery disease

Locations

Country	Name	City	State
Brazil	Incor Hospital	Brasília
Brazil	Cardiovascular Diagnóstico	Campo Grande	Mato Grosso do Sul
Brazil	Hospital Costantino Constantini	Curitiba	Paraná
Brazil	Centro de Cardiologia e Radiologia Intervencionista	Goiania	Goiás.
Brazil	Santa Casa de misericórdia de Juiz de fora	Juiz de Fora	Minas Gerais
Brazil	Hospital Albert Einstein	Sao Paulo
Brazil	Hospital Bandeirantes	Sao Paulo
Brazil	Hospital Santa Marcelina	Sao Paulo
Brazil	Incor Hospital	Sao Paulo
Brazil	Instituto Dante Pazzanese	Sao Paulo
Brazil	Instituto de Cardiologia	Sao Paulo
Brazil	Intistuto do Coracao do Triangulo	Uberlandia	Minas Gerais
Brazil	Hospital Meridional	Vitaria	Espirito Santo
India	Life Care Institute	Ahmedabad	Gujarat
India	Shri.Jayadeva Institute of Cardiology	Bangalore	Karnataka
India	Apollo Hospital	Chennai	Tamilnadu
India	Madras Medical Mission	Chennai	Tamil Nadu
India	B.M.Birla Heart Research Center	Kolkata	West Bengal
India	Sanjay Gandhi Post Graduate Institute of Medical Sciences	Lucknow	Uttar Pradesh
India	Jaslok Hospital & Research Centre	Mumbai	Maharashtra
India	KEM Hospital	Mumbai	Maharashtra
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	Escorts Heart Institute & Research Centre	New Delhi	Delhi
India	Max Devki Devi Heart and Vascular Institute	New Delhi	Delhi
India	Kailash Health Care Limited	Noida	Uttar Pradesh
India	Ruby Hall Clinic	Pune	Maharashtra
India	P.R.S Hospital	Trivandrum	Kerala
Saudi Arabia	KAUH King Abdl Aziz University Hospital	Jeddah

Sponsors (2)

Lead Sponsor	Collaborator
Sahajanand Medical Technologies Pvt. Ltd.	Cardialysis BV

Countries where clinical trial is conducted

Brazil,  India,  Saudi Arabia, 

References & Publications (2)

Dani S, Kukreja N, Parikh P, Joshi H, Prajapati J, Jain S, Thanvi S, Shah B, Dutta JP. Biodegradable-polymer-based, sirolimus-eluting Supralimus stent: 6-month angiographic and 30-month clinical follow-up results from the series I prospective study. EuroIntervention. 2008 May;4(1):59-63. — View Citation

Dr. A.Abhyankar; Evaluation of Safety, Efficacy and Procedural Outcomes of Extra Long Sirolimus Eluting Stent with novel polymeric technology for treatment of long de novo coronary lesions; Catheterization Cardiovascular Interventions; 3rd Nov - 2nd Dec 2006; DOI 10.1002/ccd.21033

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent luminal late loss at 9 months after stent implantation (off-line QCA).		9 months	No
Secondary	PROCEDURAL: Pre-procedure Syntax Score (by off-line visual assessment), Procedural success rate, Device success rate		Hospital discharge	Yes
Secondary	ANGIOGRAPHIC : Minimal lumen diameter (MLD), % diameter stenosis, In-segment late loss, Proximal late loss, Distal late loss, Binary restenosis rate		9 months	Yes
Secondary	IVUS (in a subset of patients): Minimal lumen area, Vessel volume, Lumen volume, Neointimal hyperplasia, Volume obstruction, Incomplete stent apposition, Plaque behind the stent struts		9 months	Yes
Secondary	DEVICE-ORIENTED COMPOSITE ENDPOINT : Cardiac death, MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR)		30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years	Yes
Secondary	PATIENT-ORIENTED COMPOSITE ENDPOINT : All-cause death, Any MI (including non-target vessel territory), Any repeat revascularization (including all target and non-target vessel)		30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years	Yes
Secondary	STENT THROMBOSIS		30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years	Yes